Compliance and performance are the goal of every drug manufacturer. But they don’t just happen. They are achieved when Good Manufacturing Practices (GMP) become a lifestyle shared by everyone in the organisation.
Our key services in Quality Management include:
Internal & Supplier Auditing:
- Internal audits, including “mock” inspection audits
- Global GMP auditing of:
- Active Substance Manufacturers
- Drug Product Manufacturers
- QC Laboratories
- Product specific GMP audits
- Audit and analysis of executed batch records
- Identification and evaluation of potential suppliers and contractors
Quality System Development & Maintenance:
- Development and implementation of effective cGMP pharmaceutical systems
- Follow up assessment and continuous improvement
- Product quality reviews
- Computer based Quality Assurance support systems
Qualification and validation:
- Equipment
- Processes and systems (including computer based systems)
- Cleaning
- Technology transfer
Learn more about our track record in Quality Management Support:
pdf-file
« back to overview